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Home/Legal & Regulatory and Reimbursement/DOJ: Biomet Breached Deferred Prosecution Agreement
Legal & Regulatory and Reimbursement

DOJ: Biomet Breached Deferred Prosecution Agreement

June 16, 2016 1 min read Premium comments

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DOJ: Biomet Breached Deferred Prosecution Agreement
Photo creation by RRY Publications, LLC and courtesy of Zimmer Biomet
Secondary

When Zimmer Holdings, Inc. purchased Biomet, Inc., Zimmer management was well aware that Biomet was under the cloud of a 2012 deferred prosecution agreement (DPA) with U.S. Justice Department to resolve a foreign corruption investigation (FCPA).

The DPA was extended for successive years as prosecutors continued to investigate Biomet’s conduct.

Now that cloud has gotten darker as prosecutors say Biomet has breached the DPA.

Prosecutors filed a status report in Washington, D.C. on June 6, 2016, alleging the breach. The finding could mean that Zimmer Biomet Holdings, Inc., could face criminal prosecution, though the Justice Department said the company had pledged to cooperate and was in “discussions to resolve this matter which would obviate the need for a trial.”

Biomet entered into the 2012 DPA to settle allegations that it paid bribes to state-employed healthcare providers in Argentina, Brazil and China in order to secure business with hospitals. According to the government, Biomet disguised the alleged bribes in its financial reports as “commissions, ” “consulting fees, ” “royalties” and “scientific incentives.”

As part of the DPA, Biomet agreed to pay a $17.3 million criminal penalty, along with a $5.4 million civil settlement to the U.S. Securities and Exchange Commission, and to maintain a compliance program to prevent future misconduct.

According to the DOJ filing, Biomet breached the DPA, “based on conduct in Brazil and Mexico that was disclosed by the company in 2014 and based on Biomet’s failure to implement and maintain a compliance program designed to prevent and detect violations of the FCPA and other anti-corruption laws.”

Jeff Binder, the CEO of Biomet at the time of the alleged bribes is no longer with the company.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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